Introduction

With the expanding array of therapeutic options in Crohn’s disease and ulcerative colitis, it is important to understand patient priorities regarding disease management goals in addition to those of healthcare professionals (HCPs). Views on Inflammatory Bowel Disease (IBD) Expectations and Well-being - Patients and Treatment providers (VIEW-PT): an analysis based on the IBD Disease Specific Programme (DSP)™, previously identified features of optimal disease control, with inclusion of patient and HCP perspectives¹. In order to aid with development of IBD management plans, this study aims to assess the prevalence of optimal disease control and associated factors in a real-world setting.

Aims & Methods

Features of optimal disease control identified in VIEW-PT¹ were used to evaluate prevalence and factors associated with IBD disease control. Data were drawn from the IBD DSP, a cross-sectional survey, with retrospective data collection, of HCPs and their patients with IBD in EU5 (France, Germany, Italy, Spain, the United Kingdom), and the United States of America, collected 2020-21 and 2023-24. Patients with a history of moderate-to-severe disease were included. HCPs reported patient demographics, clinical characteristics, treatment history, healthcare resource utilisation and whether treatment targets were set and subsequently achieved. Patients self-reported sex, symptoms, involvement in their current treatment decision and health-related quality of life via Visual Analogue Scale (EQ-VAS). Patients without key symptoms (bleeding, bowel urgency, fecal incontinence, abdominal pain, fatigue), and with restored bowel movement frequency, extraintestinal manifestations control, complete mucosal healing, no steroid use, no sleep disturbance, and EQ-VAS ≥80^2,3 were considered to have optimal disease control. Logistic regression was performed to determine association of factors with optimal disease control, with odds ratios (OR) and p-values reported.

Results

Of 2614 patients with IBD, just 10.0% had optimal disease control aligned with features identified in VIEW-PT¹. Patient demographics are in Table 1a. Logistic regression analysis included 1833 patients with complete data (Table 1b). Patients involved in treatment decisions (OR=4.82, p<0.001) and patients who achieved their set treatment targets (OR=2.17, p=0.002) had higher odds of achieving optimal disease control, while patients who had not achieved their set treatment targets (OR=0.31, p=0.002) had lower odds of achieving optimal disease control. Other factors associated with optimal disease control included a previous history of smoking (OR=2.13, p=0.004) or having never smoked (OR=1.91, p=0.013), having a psychological comorbidity (OR=0.27, p=0.002), not receiving advanced therapy (OR=0.54, p=0.005), and having >4 HCP visits in the past 12 months (OR=0.42, p<0.001).

Conclusion

Patient involvement in treatment decisions and achievement of treatment targets were most strongly associated with optimal disease control in patients with IBD. Other significantly associated factors included no psychological comorbidities, none or ex-smoking status, and advanced therapy prescription. This real-world evidence suggests that involving patients in treatment decisions and setting and reaching targets may support achievement of optimal disease control in patients with IBD.

References

1. Rubin et al. J Crohn’s Colitis. 2025 Jan 1;19(1): i1376-i1377.
2. Jiang et al. Qual Life Res. 2021; 30(3):803-816.
3. Janssen et al. Eur J Health Econ. 2021;22(9):1467-1475.

Disclosure

MD has received consultant and advisory fees from Abbvie, Abivax, Astra Zeneca, Boehringer Ingelheim International GmbH, Bristol-Meyer Squibb, Celltrion, Eli Lilly and Company, Genentech , Janssen Pharmaceuticals, Johnson and Johnson, Merck, Pfizer Inc, Prometheus Labs, Sanofi, Spyre, Takeda Pharmaceuticals.

ST has received grants/research support from AbbVie, Celgene, Celsius, ECCO, Galapagos, GSK, Helmsley Trust, IOIBD, Janssen, Eli Lilly and company, Pfizer, Takeda, UKIERI, Vifor, and Norman Collisson Foundation;
consulting fees from Alimentiv, Apexian, Apollo, Arcturis, AstraZeneca, BMS, Clario, Cosmo, Endpoint Health, EQrX, Equillium, Ferring, Galapagos, Genentech/Roche, Gilead, GSK, Janssen, Iterative Health, Eli Lilly and company, Mestag, Microbiotica, ONO, Pfizer, Phesi, Protagonist, Sanofi, Satisfai, Sensyne Health, Spyre, Takeda, Teva, Theravance, Tr1X Bio; has received speaker fees from BMS, Ferring, GSK, Janssen, Eli Lilly and company, Pfizer, Sun Pharma, Takeda; and has share options from Satisfai Health Inc.

APB, EK and SF are employees of Eli Lilly and Company and may hold stock or stock options.

GM is part of the speaker bureau for Lilly- 2023-present, Omvoh (mirikizumab); and Pfizer, 2018-present, Xeljanz (tofacitinib), Velsipity (etrasimod)

NA has no conflict of interest to disclose.

LW has no conflict of interest to disclose.

CO is a former employee and shareholder of Eli Lilly and Company.

XZ has no conflict of interest to disclose.

VP and GC are employees of Adelphi Real World.

RP is a consultant for Abbott, AbbVie, Abbivax, Alimentiv,Amgen, AnaptysBio, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly and company, Ferring, Galapagos, Inviva, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mirador, Novartis, Oppilan Pharma, Odyssey, Organon, Pandion.

Introduction

Mirikizumab is a humanized IgG4 monoclonal, anti-interleukin-23p19 antibody. VIVID-2 (NCT04232553), an ongoing open-label study, has demonstrated sustained clinical and endoscopic efficacy at 2 years of treatment of mirikizumab for Crohn’s disease (CD).¹ Here we present the long-term quality of life (QoL) up to 2 years from VIVID-2.

Aims & Methods

Patients enrolled in the phase 3 VIVID-1 study who achieved an endoscopic response to mirikizumab continued maintenance treatment in VIVID-2, while endoscopic non-responders received mirikizumab induction therapy followed by maintenance treatment. Quality of life was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The proportion of patients who achieved IBDQ response/remission, as well as mean changes from VIVID-1 baseline in IBDQ total scores at W64 and104 were reported. EQ-5D-5L Visual Analog Scale (VAS) scores (range 0-100, with 100 being best imaginable health state) were assessed at W64. Work productivity was assessed at W64 using Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI:CD) (4 scores including absenteeism, presenteeism, work productivity loss and activity impairment are derived as percentages with higher values indicating greater impairment). Modified non-responder imputation (mNRI) was used for binary missing data imputation, and modified baseline observation carried forward (mBOCF) was used for continuous missing data imputation. Estimates of mean changes from baseline were calculated with analysis of covariance (ANCOVA).

Results

Analysis of endoscopic responders showed IBDQ response and IBDQ remission were maintained through W104 (85.0% and 71.3%, respectively) while endoscopic non-responders also maintained IBDQ response and remission through the same time (72.6% and 60.8%, respectively). (Table 1) Mean change from baseline in IBDQ total score was maintained through W104 for endoscopic responders and non-responders (least squares mean (standard error); 57.2 (2.1) and 46.8 (2.4), respectively). Similarly, EQ-5D-5L VAS improvement was observed for both groups at W64 (27.0 (1.0) and 22.3 (1.2), respectively). WPAI:CD improvements in both groups ranged from −13.9 (1.8) to −34.3 (1.5) for the different scores collected at W64.

Conclusion

Patients continuing mirikizumab maintenance and those receiving reinduction achieved meaningful long-term QoL improvement that was maintained at 2 years of treatment.

References

1. Barnes E, Sands B, D'Haens G, et al. Long-term efficacy and safety of mirikizumab following 104 weeks of continuous treatment for Crohn's disease: results from the VIVID-2 open-label extension study. Gastroenterology. 2025;168(3 Suppl):S14-S15. doi:10.1053/j.gastro.2025.01.073.

Introduction

Mirikizumab is an interleukin (IL)-23 inhibitor approved for the treatment of ulcerative colitis (UC); however, real-world data are limited.

Aims & Methods

The Dutch Initiative on Crohn and Colitis (ICC) Registry is a prospective multicentre study collecting real-world data on advanced therapeutic agents in inflammatory bowel disease (IBD). Patients included in the current study had a confirmed diagnosis of UC and received at least one intravenous induction dose of mirkizumab before the 28^th of February 2025. Patients who did not use at least two therapies with different mechanisms of action (i.e. difficult-to-treat UC) or with colectomy were excluded. The primary endpoint was clinical remission at week (W) 12, defined as Simple Clinical Colitis Activity Index (SCCAI) ≤ 2. Secondary outcomes at W12 included corticosteroid-free (CSF) clinical remission (i.e. clinical remission without the use of systemic corticosteroids on the day of the visit), biochemical remission (faecal calprotectin (FC) level ≤ 250μg/g) and endoscopic remission (Mayo endoscopic subscore = 0). In addition, drug survival and adverse events were assessed.

Results

In total, 22 patients were included; 13 (59.1%) were male. Most patients (n = 12; 54.5%) were diagnosed with pancolitis. Patients had a median disease duration of 9.5 years (IQR 18.0). Twelve patients (54.5%) had used at least four different advanced therapies; 19 (86.4%) patients have previously used ustekinumab (IL-12/23 inhibitor). At treatment initiation, all patients showed active disease, either clinically, biochemically or endoscopically. Median SCCAI was 7.0 (IQR 6); median FC was 1696.5μg/g (IQR 2079). As the study is still ongoing, data at W12 were available for 19 (86.4%) patients. Clinical data were available for 14 patients; 35.7% (5/14) of them were in clinical remission. These five patients were also in CSF clinical remission. Similar rates were observed between ustekinumab-experienced and ustekinumab-naïve patients, although the naïve subgroup was rather small (3/14). Biochemical data were available for 12 patients; median FC was 1434.5μg/g (IQR 824). Only one (8.3%) patient was in biochemical remission at W12; this patient was ustekinumab-naïve. Another patient, with only endoscopic data, was in endoscopic remission. Two patients discontinued mirikizumab before W12: one patient stopped mirikizumab after the intravenous injection because of fever; the other patient showed no response. Four other patients discontinued mirikizumab after W12; none of them were in clinical or biochemical remission at W12. Reasons for treatment discontinuation were primary non-response (5/6) and adverse event (1/6). Four adverse events were reported in four patients: nausea and skin problems, both classified as possibly related to the treatment, a gastrointestinal infection requiring antibiotics and fever during the infusion.

Conclusion

We found that 7/16 patients with difficult-to-treat UC were in either clinical, biochemical or endoscopic remission at W12. Moreover, all patients in clinical remission at W12 were not using other medications. Mirikizumab was well tolerated, although the follow-up period was relatively short. The ICC Registry is ongoing, and results with higher patient numbers with longer exposure to mirikizumab will be analysed to further characterise the real-world effectiveness and safety for patients with difficult-to-treat UC.

Disclosure

LMMV - none MRN - none ACdV - advisory boards for Takeda, Janssen, Bristol Myers Squibb, Abbvie, Pfizer, and Galapagos; research grants from Takeda, Janssen, and Pfizer WAvD - none MCV - speaker fees from Janssen-Cilag, Galapagos, and Ferring B.V. IM - advisory board/lecture fee from Abbvie, dr. Falk, and Janssen-Cilag FDMvS - adviser and/or speaker for Takeda, Galapagos, Dr. Falk, Lilly, and Janssen-Cilag; received an unrestricted grant from Takeda JMJ -consultant/speaker for AbbVie, Lilly, Takeda, and Janssen; consultant for MSD AGLB - none ML - consultancy/lecture fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen-Cilag, Johnson & Johnson, Medtronic, Pfizer, Takeda, and Tillotts Pharma; grants from Alfasigma, the Netherlands Federation of University Medical Centres, TKI, and ZonMW AEvdMDJ - speaker fee from AbbVie, Alfasigma, Ferring, Janssen Pharmaceuticals, Takeda, Tramedico, and Vedanta; grants from Norgine, Cablon, Alfasigma, and ZonMW MJP - speaker fee from BMS, Janssen Cilag, and Takeda; non-restricted research grants from Horizon 2020, ZONMW (Dutch national research fund), MLDS, Takeda, Johnson and Johnson, Abbvie, and Galapagos ZM - speaker fee from Friso – Friesland Campina, Galapagos, Eli Lilly, and Takeda (paid to host institution); advisory board fees from Johnson & Johnson, Eli Lilly, Pfizer (paid to host institution); grants from ZonMw, Niels Stensen Fellowship, MLDS, Top consortium for Knowledge and Innovation (TKI), and Galapagos MD - speaking fee from Bristol Meyers Squibb, Takeda, Galapagos, Janssen, and Dr. Falk; advisory board fees from Abbvie, Bristol Meyers Squibb, Celltrion, Galapagos/Alfasigma, Janssen, Takeda; grant/research support from Pfizer, Bristol Meyers Squibb, Galapagos Alfasigma, and Janssen

Introduction

Mirikizumab (MIRI) is an anti-IL-23p19 antibody with demonstrated efficacy compared to placebo (PBO) in the treatment of moderately-to-severely active ulcerative colitis (UC) (LUCENT-1: NCT03518086; LUCENT-2: NCT03524092).¹ Prevention of IBD-related surgery and hospitalizations is a goal in disease-modification trials for preventing disease progression.² We described the rates of these events in the LUCENT-1 and -2 trials.

Aims & Methods

Patients were randomized to intravenous MIRI 300 mg or PBO every 4 weeks (Q4W) for induction in LUCENT-1. Patients randomized to MIRI induction and achieving clinical response at Week (W)12 were re-randomized 2:1 in LUCENT-2 to subcutaneous MIRI 200 mg Q4W or PBO (MIRI withdrawal) for maintenance (W12-52). Descriptive statistics were used for proportion of patients in LUCENT-1 and -2 who had hospitalization and/or surgery by treatment group and the exposure-adjusted incident rate (IR). For LUCENT-1, hospitalizations in the induction period and surgeries during the induction and 16-week follow-up period were included. For LUCENT-2, all events were from the on-treatment period. Only hospitalizations associated with an adverse event with ≥24-hour stay (for any causes) were recorded.

Results

MIRI-treated patients had significantly lower IR of overall hospitalization, UC-related hospitalization, and overall surgery vs PBO-treated patients in LUCENT-1 (IR ratio MIRI vs PBO: 0.4, 0.1, 0.4, respectively). IR of UC-related surgery was 1.3 per 100 patient-years in MIRI-treated patients vs 2.6 per 100 patient-years in PBO group (Table). Mean time to first surgery or hospitalization from randomization was 30.5 days for PBO and 58.7 days for MIRI. Additional analyses revealed that patients on MIRI who had surgery/hospitalization in LUCENT-1 or -2 tended to have prior biologic failure and longer duration of disease. Similarly, in LUCENT-2, MIRI-treated patients had significantly lower IR of all-cause hospitalization and similar all-cause surgery vs PBO. No UC-related hospitalization and surgery were reported in the MIRI group while 2 UC-related hospitalizations (1.8 per 100 person-years) were reported from PBO.

Conclusion

Lower rates of UC-related hospitalizations and UC-related surgery were observed in patients treated with MIRI compared to those treated with PBO during the 12W induction LUCENT-1, and that impact continued through the 40W of maintenance LUCENT-2 with no UC-related hospitalizations or UC-related surgery reported in MIRI-treated patients.

References

1. D’Haens G, et al. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine 2023;388(26):2444-2455.
2. Le Berre C, Peyrin-Biroulet L. Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD. Gastroenterology 2021;160(5):1452-1460.e21.

Disclosure

MR serves as a consultant and on advisory boards for AbbVie, Janssen, Bristol-Myers Squibb, UCB, Takeda, Pfizer, Prometheus Laboratories, Lilly, Celgene, and Amgen.
LPB has served as a consultant for AbbVie, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Pfizer, Prometheus, Protagonist, Roche, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax; he received grants from Takeda, Fresenius Kabi, Celltrion; he served as a speaker for Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Sandoz, Biogen, MSD, Amgen, Vifor, Arena, Lilly, Gilead, Viatris, Medac; he also declares support travel by Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Gossamer Bio, Sandoz, MSD, Amgen, Lilly, Gilead, Thermo Fisher, Medac, CONNECT Biopharm; he declares stock options of Clinical trials Mobile Application.
JW, BZ, IR, KT, CO are employees and minor shareholders of Eli Lilly and Company.
SN has served on advisory board and speaker for Eli Lilly and Company, Pfizer and advisory board for madrigal and speaker for Janssen
TK has served as a paid consultant for Abbvie, Amgen, Biogen, Mundipharma, Hospira, Gilead, Janssen, Pfizer, MSD Sharp & Dome GmbH, and Novartis. He has received reimbursement of meeting participation fees and of travel and accommodation expenses from Abbvie, Janssen, MSD, and Takeda. He has received honoraria for preparing continuing medical education events from Abbvie, Falk, Janssen, MSD, Takeda, and Ferring Arzneimittel GmbH.
LM reports educational grants from Abbvie, Janssen, Pfizer and Takeda; advisory boards: AbbVie, Bristol Myers Squibb, Janssen, and Celltrion; consultant for Abbvie, Pfizer and Pharmacosmos.
FM has served as a speaker and received honoraria from Merck Sharp & Dohme, Abbvie, Vifor, Falk, Laboratorios Vitoria, Ferring, Hospira, and Biogen.

Introduction

Steroid-refractory acute severe ulcerative colitis (SR-ASUC) is a life-threatening emergency that results in colectomy in approximately 40% of cases.¹ Several medical therapies have emerged as rescue treatments aimed at reducing the need for colectomy.^2-3However, direct comparative studies evaluating the relative efficacy of these therapies remain limited.⁴ This network meta-analysis aims to systematically review and compare the efficacy and safety of available rescue therapies for SR-ASUC, including biologics and small molecule treatments.

Aims & Methods

A systematic literature search was conducted using the MEDLINE, SCOPUS, and CENTRAL databases. Colectomy-free survival probabilities were extracted from Kaplan-Meier curves. A one-stage network meta-analysis using parametric Weibull regression was performed to estimate and compare the relative treatment effects of biologics and small molecule therapies. The primary outcome was colectomy-free survival at 4 and 12 weeks. This study was registered in PROSPERO (CRD420251030353).

Results

A total of 18 studies (5 randomized controlled trials and 13 cohort studies), including 1,706 patients with SR-ASUC, were included. Compared to placebo, standard-dose infliximab [hazard ratio (HR) 0.34, 95% CI: 0.20–0.60, p < 0.001], accelerated-dose infliximab [HR 0.38, 95% CI: 0.21–0.68, p = 0.001], and tofacitinib [HR 0.36, 95% CI: 0.19–0.69, p = 0.002] significantly improved colectomy-free survival. Cyclosporine also showed a trend toward reduced colectomy risk, though it did not reach statistical significance [HR 0.57, 95% CI: 0.31–1.01, p = 0.056]. There were no significant differences in overall adverse events or infection rates among the therapies. Based on SUCRA rankings, colectomy-free survival at both 4 and 12 weeks was highest for tofacitinib (SUCRA: 0.90 and 0.87), followed by accelerated-dose infliximab (0.95 and 0.85), standard-dose infliximab (0.87 and 0.83), and cyclosporine (0.81 and 0.74). (Figure 1 Colectomy free survival probability ; Kaplan-Meier curves)
Table 1. Pairwise table showing comparative efficacy in reducing colectomy risk of biologics and small molecule for SR-ASUC

Conclusion

Tofacitinib and accelerated-dose infliximab appear to be the most effective rescue therapies for improving colectomy-free survival in patients with SR-ASUC.

References

1. Dong C, Metzger M, Holsbø E, et al. Aliment Pharmacol Ther. 2020 Jan;51(1):8-33.
2. Honap S, Jairath V, Sands BE, et al. Gut. 2024 Sep 9;73(10):1763-1773.
3. Calméjane L, Laharie D, Kirchgesner J, et al. United European Gastroenterol J. 2023 Oct;11(8):722-732.
4. Choy MC, Seah D, Faleck DM, et al. Inflamm Bowel Dis. 2019 Jun 18;25(7):1169-1186.